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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFemoral Introducer Sheath and Hemostasis(FISH) Device
Generic NameDevice, hemostasis, vascular
ApplicantMorris Innovative Research, Inc.
907 W. Second St.
Bloomington, IN 47403
PMA NumberP050043
Supplement NumberS008
Date Received07/30/2018
Decision Date09/19/2018
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replacement of the current laser cutting equipment with a new laser cutting equipment for the SIS patch cutting operation.
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